Flanged heart tissue blocker

ABSTRACT

An apparatus for protecting heart tissue from an implanted inlet element of a blood pump. The apparatus includes a flange member having a first radially constricted configuration and a second radially expanded configuration, the flange member being biased in its second radially expanded configuration. The flange member defines an opening there through sized to receiving the inlet element of the blood pump. A retaining element extending from the flange member is included, the retaining element being flexible and sized to be disposed about at least a portion of the inlet element.

CROSS-REFERENCE TO RELATED APPLICATION

This application is related to and claims priority to U.S. ProvisionalPatent Application Ser. No. 62/315,260, filed Mar. 30, 2016, entitledFLANGED HEART TISSUE BLOCKER, the entirety of which is incorporatedherein by reference.

STATEMENT REGARDING FEDERALLY SPONSORED RESEARCH OR DEVELOPMENT

n/a

TECHNICAL FIELD

The present invention relates to components and methods used inconnection with implanted heart devices, such as ventricular assistdevices and other associated elements.

BACKGROUND

The heart is sometimes incapable of providing sufficient pumpingcapacity to meet the needs of the body. The effects of this inadequacycan be alleviated by providing a mechanical pump referred to as amechanical circulatory support device (“MCSD”). An MCSD can be implantedto supplement the pumping action of the heart, most commonly for anextended period of time such as several years.

An MCSD is most commonly connected to the left ventricle. In thisarrangement, an inlet end of the pump, or an inlet cannula connected tothe inlet end of the pump, is implanted in the wall of the ventricle,such as at the apex of the ventricle. An outlet cannula is connectedbetween the outlet end of the pump and an artery such as the aorta.MCSDs which are connected to a ventricle commonly are referred to asventricular assist devices or “VADs.” During operation, the MCSD assiststhe heart to pump blood from the left ventricle to the aorta.

MCSDs are typically connected to the heart through the use of a mountingelement such as a mounting ring. In use of such a mounting ring, themounting ring is secured to the outside of the heart by suturing orother fastening techniques. A separate surgical tool is used to core ahole in the heart within the ring. An inlet cannula or other inletelement of the MCSD may then be inserted through the hole into theheart. The mounting ring may then be tightened to secure the MCSD to thering and thus secure the MCSD to the heart.

In some instances, the heart wall, thrombus disposed on the heart wall,or other tissues or deposits may be drawn into the inlet element.Tissues or deposits drawn into the inlet element may block the flow ofblood into the inlet element and may cause other complications.

SUMMARY

The present invention advantageously provides an apparatus forprotecting heart tissue from an implanted inlet element of a blood pump.The apparatus includes a flange member having a first radiallyconstricted configuration and a second radially expanded configuration,the flange member being biased in its second radially expandedconfiguration. The flange member defines an opening there through sizedto receiving the inlet element of the blood pump. A retaining elementextending from the flange member is included, the retaining elementbeing flexible and sized to be disposed about at least a portion of theinlet element.

In another aspect on this embodiment, a mounting element is includedconfigured for fastening to an exterior surface of the wall of the heartindependently of the flange member and the retaining element, themounting element being configured to retain the implanted inlet elementin position relative to the heart, the retaining element beingconfigured to engage the mounting element.

In another aspect on this embodiment, the mounting element defines abore and is sized to receive the implanted inlet element and theretaining element within the bore.

In another aspect on this embodiment, the mounting element includes aclamp configured to constrict the bore and engage the retaining elementbetween the implanted inlet element and the mounting element.

In another aspect on this embodiment, the retaining element defines atubular body having a proximal end and a distal end, and wherein thetubular body defines an annular pocket distal to the distal end of thetubular body, and wherein the flange member includes a flexible washerdisposed within the annular pocket.

In another aspect on this embodiment, the tubular body includes aplurality of perforation lines extending distally from the proximal endof the tubular body.

In another aspect on this embodiment, the retaining elements includes atleast one from group consisting of a knitted material and polyester.

In another aspect on this embodiment, the flange member includes aplurality of radially disposed ribs, wherein the ribs are configured tobias the flange member in its radially expanded configuration.

In another aspect on this embodiment, the flange member includes aplurality of radially disposed apertures, the radially disposedapertures being sized to promote cardiac tissue ingrowth.

In another aspect on this embodiment, a flexible layer of materialcircumferentially disposed around a portion of the retaining element isincluded, the flexible layer of material configured to prevent seepageof blood from the heart into an interior of the retaining element.

In another embodiment, a method implanting an apparatus for protectingheart tissue from an implanted inlet element of a blood pump includesadvancing a flange member in a radially constricted configurationthrough an opening of a heart wall, the flange member including aretaining element defining a tubular body extending proximally out ofthe heart through the opening, the flange member being configured totransition to a radially expanded configuration after passage throughthe opening of the heart wall. The flange member and the retainingelement are positioned to overlie an interior surface of the heart wallsurrounding the opening.

In another aspect of this embodiment, the method further includesmounting the inlet element of the blood pump to the heart, and whereinmounting of the inlet element of the blood pump further includesadvancing the inlet element through the opening of the heart wall beyondthe flange member.

In another aspect of this embodiment, mounting the inlet elementincludes fastening a mounting element on the exterior of the heart wallindependently of the flange member.

In another aspect of this embodiment, mounting the inlet element furtherincludes engaging the mounting element to retain the inlet element inposition relative to the mounting member and to retain the retainingelement in position relative to the mounting member.

In another aspect of this embodiment, fastening the mounting element tothe heart is performed before advancing the flange member through theopening in the heart wall, and wherein the mounting element defines abore, and wherein the flange member is advanced through the bore intothe opening and the retaining element extends through the bore afteradvancement of the flange member through the opening.

In another aspect of this embodiment, engaging the mounting elementincludes constricting the bore of the mounting element to retain theretaining element between the inlet element and the bore of mountingelement.

In another aspect of this embodiment, the method further includesseparating a portion of the tubular body adjacent a proximal end of thetubular body remote from the flange member into strips and folding thestrips outwardly from the tubular body.

In another aspect of this embodiment, advancing the flange memberthrough the opening of the heart wall further includes placing theflange member within a guiding tube having an open distal end; advancingthe open end of the guiding tube through the opening of the heart wall;and advancing the flange member through the open distal end of theguiding tube.

In another aspect of this embodiment, the flange member is resilient andbiased in the radially expanded configuration.

In yet another embodiment, an apparatus for protecting heart tissue froman implanted inlet element of a blood pump includes a flange memberhaving a first radially constricted configuration and a second radiallyexpanded configuration, the flange member being biased in its secondradially expanded configuration, the flange member defining an openingthere through sized to receiving the inlet element of the blood pump,the flange member defining an annular pocket and including a flexiblewasher disposed within the pocket, the flexible washer including aplurality of radially disposed ribs and apertures. A retaining elementextends proximally from the flange member, the retaining element beingflexible and radially disposed about the opening, the retaining elementdefining a tubular body defining a plurality of tearable strips, thetubular body defining a lumen coaxial with the opening of the flangemember.

BRIEF DESCRIPTION OF THE DRAWINGS

The present application will become better understood with regard to thefollowing description and accompanying drawings in which:

FIG. 1 is a perspective view of apparatus in accordance with oneembodiment of the application;

FIG. 2 is another perspective view of the apparatus of FIG. 1;

FIG. 3 is another perspective view of the apparatus of FIGS. 1 and 2 inconjunction with an MCSD;

FIGS. 4 and 5 are diagrammatic cross-sectional views depicting portionsof the apparatus of FIGS. 1 and 2;

FIG. 6 is a view similar to FIGS. 4 and 5 but depicting the apparatus inconjunction with an MCSD;

FIG. 7 is a cross-sectional view of another apparatus according to afurther embodiment of the invention;

FIG. 8 is a flow diagram in accordance with aspects of the application;and

FIG. 9 is a diagrammatic perspective view of a component according toyet another embodiment of the application.

DETAILED DESCRIPTION

Referring now to the drawings in which like designators refer to likeelements, there is shown in FIG. 1 an apparatus for protecting hearttissue from an implanted inlet element of a blood pump constructed inaccordance with the principles of the present application and designatedgenerally as 100. The apparatus 100 may include a flange member 10 and aretaining element 12, which in one embodiment, define a hollow tubularbody 14. The member 10 has an inner edge 16 that defines an opening 18into the hollow tubular body 14. The flange member 10 also has an outeredge 20 that defines a radial extent of flange member 10. The tubularbody 14 may be composed of a flexible material such as composed of oneor more layers of a biocompatible fabric, plastic, or metal. Forexample, tubular body 14 may be composed of one or more composite layersof knitted polymers, such as polyethylene terephthalate (“PET”).

Continuing to refer to FIG. 1, tubular body 14 has a distal end 22 and aproximal end 24. The tubular body 14 has interior diameter large enoughto pass the inlet element of an MCSD as discussed below, typically onthe order of 16-20 mm. In one configuration, the tubular body 14 isflexible but has sufficient stiffness to retain its shape so that itdoes not bend or close under the influence of gravity. A fabric may beprovided with a medically acceptable coating such as a lacquer toincrease its stiffness. For example, the retaining element 12 mayinclude a flexible layer of material 26, for example, silicone,impregnated within the fabric that defines the retaining element 12 orotherwise is circumferentially disposed around a portion of theretaining element 12. The flexible layer of material 26 is configured toprevent seepage of blood from the heart into an interior of theretaining element 12. In one configuration, the flexible layer ofmaterial 26 defines a height greater than the thickness of the heartwell. Alternatively or additionally, the retaining element 12 mayinclude multiple layers of fabric. A plurality of tear lines 28 mayextend from the proximal end 24, at least of part of the distal to thedistal end 22. The material of the tubular body 14 may be weakened alongthe tear lines 28, so as to allow at least a portion of tubular body 14adjacent the proximal end 24 to be separated into teardown strips 30during use, as further discussed below. For example, the material of thetubular body 14 may be perforated, scored or partially cut along thetear lines 28 during manufacture.

The tubular body 14 includes an annular pocket 32 adjacent distal end 22and distal to the tear lines 28. Annular pocket 32 extends around thetubular body 14. For example, where the tubular body 14 is formed from atextile, the annular pocket 32 may be manufactured on a tubular knittingmachine so that the annular pocket 32 can be formed during manufacture,without stretching the material of the tubular body. In oneconfiguration, the flange member 10 is composed of a flexible washer 34that is disposed in the annular pocket 32 so that the flange member 10includes both the flexible washer 34 and the material of the tubularbody 14 forming the annular pocket 32. Flexible washer 34 may becomposed of any number of flexible materials, including rubbers,polymers such as PET or silicone. Flexible washer 34 may have athickness that allows for sufficient flexibility and radial constrictionas discussed below. For example, the flexible washer 34 may have athickness between 2 and 3 millimeters. Washer 34 may further includeinterior diameter equal to or slightly greater than the interiordiameter of tubular body 14. During manufacture, flexible washer 34 maybe positioned within annular pocket 32 while the annular pocket 34 isopen as shown in FIG. 4. Once flexible washer 34 is positioned withinthe annular pocket 34, it optionally may be bonded or sewn into place.For example, where the tubular body 14 includes a portion projectingdistally beyond the annular pocket 32, this portion may be folded backproximally within the tubular body 14 so as to cover the inner edge 16of flexible washer 34. The folded flexible material may then be sewn orotherwise attached to the inside portion of tubular body 14, so as tomaintain flexible washer 34 within annular pocket 32.

Continuing to refer to FIG. 1, a mounting ring 200 may be included andconfigured to engage at least a portion of the retaining element 12. Themounting ring 200 may a conventional mounting ring as, for example, thea mounting ring as disclosed in U.S. Published Patent Application Nos.2004/0171905, 2007/0134993, and 2015/0112120, the disclosures of whichare hereby incorporated by reference herein. The mounting ring has abody 202 with elements defining a bore 204 extending through the body202, and also has features which can be used to attach the body 202 tothe outside of the heart wall so that the bore 204 extends towards andaway from the wall. In the example shown, the body 202 includes with abase plate 206 on a distal side of the ring 200 which faces toward theheart when the ring 200 is installed, and a ring of fabric schematicallyindicated in broken lines at 208 attached to the base plate 206 andencircling the body 202. A mounting ring 200 of this type can be securedin place by suturing the fabric ring to the exterior of the heart. Othermounting rings are equipped with barbs or other fasteners for attachingthe body of the ring to the heart wall. The mounting ring is arranged sothat a portion of the body defining at least part of the main bore 204is compressible to constrict the bore 204 around an inlet element of theMCSD to hold the element in place. As shown, for example, in U.S.Published Patent Application No. 2007/0134993, the body 202 may includedeformable elements such as a pair of generally C-shaped arms (notshown) on opposite sides of the bore 204, so that the bore 204 can beconstricted by forcing the arms toward one another. The body 202 mayalso include an element referred to as a gimbal ring (not shown)defining all or part of bore 204, the gimbal ring be arranged to tiltthrough a limited range of motion relative to the base plate 206 toallow the inlet element of the to tilt relative to the base plate 206during installation. The mounting ring 200 may further includes a clamp210 (FIG. 6) configured to deform the body 202 so as to constrict thebore 204. A guiding tube 300 (FIG. 5) formed from a substantially rigidmaterial such as a metal and having an outside diameter may be includedand configured to fit within the bore 204 of the mounting ring 200 whilethe bore 204 is in an unconstructed state. Guiding tube 300 may includea thin wall and may further include a stop member 302 projectingoutwardly adjacent a proximal end of the guiding tube 300. A pusher tube304, also formed from a thin, rigid material, is slidably receivedwithin guiding tube 300. The pusher tube 304 may have a stop 306projecting outwardly at its proximal end.

In a method according to a further aspect of the disclosure,schematically depicted in the flow chart of FIG. 8, the mounting ring200 may fixed to the to the outer surface 36 of heart wall 38 (FIG. 5),such as by suturing fabric ring 208 to the heart wall 38 (step 802). Acoring tool (not shown) is used to form a hole in the heart wall 38 inalignment with the bore 204 of the mounting ring 200 (step 804). Theflange member 10 may be deformed from a second radially expandedconfiguration in which the flange member is biased in a radiallyexpanded configuration or condition (depicted in FIGS. 1-4) to a firstradially constricted configuration or condition depicted in FIG. 5 (step806). In this radially constricted condition, the flange member 10 has adiameter less than the diameter of the bore 204. In this condition, thedistal end 22 of tubular body 14 may be partially or completelycollapsed. The flange member 10 and the distal end 22 of retainingelement 12 are passed through the bore 204 of the mounting ring 200 andthrough the hole in the heart wall 38, while leaving the proximal end 24of the retaining element 12 outside of the heart and proximal to themounting ring 200 (step 808). This may be done by positioning thetubular body 14 inside guiding tube 300 and pusher tube 304, with theflange member 10 disposed distal to the pusher tube 304, and advancingthe guiding tube 300 through the mounting ring 200 until the distal endof the guiding tube 300 is just inside the heart, i.e., just past theinterior surface the heart wall as depicted in FIG. 5. The stop member302 of the guiding tube 300 may engage the proximal side of the mountingring body 202 to prevent excessive advancement of the guiding tube 300.The flange member 10 may be brought to its radially-expanded conditionand positioned to overlie the interior surface of the heart wall 38.This can be done by advancing pusher tube 304 within the guiding tube300, so as to push the flange member 10 out of the guiding tube 300through its distal end. The inner surface of guiding tube 300 may have alow coefficient of friction with flange member 10 so as to allow theflange to easily slide through guiding tube 300.

When the flange member 10 is clear of the guiding tube 300, the flangemember 10 transitions back to its radially-expanded condition. Stopmember 302 on the pusher tube 304 may engage the pusher tube 304 andarrest the distal movement of the pusher tube 304 when the distal end ofthe pusher tube 304 reaches the distal end of the guiding tube 300. Oncethe annular washer 34 has been ejected from the guiding tube 300, theguiding tube 300 and pusher tube 304 may be removed by sliding themproximally relative to the mounting ring 200 and retaining element 12.The physician may, for example, manually grasp the retaining element 12adjacent its proximal end and pull it proximally to seat the annularwasher 34 against the interior surface. At this stage of the process,the apparatus 100 has the configuration shown in FIG. 1.

The proximal end 24 of the retaining element 12 may be separated intostrips 30, by tearing along tear lines 28 (FIG. 4), and the strips 30may be folded outwardly, away from the bore of the mounting ring 200, tothe configuration depicted in FIG. 2 (step 812). In this condition, theretaining element 12 does may not protrude from the proximal end of themounting ring 200. The physician may maintain the position of the flangemember 10 within the heart by holding one or more of the strips 30.Alternatively, the physician may suture one or more of the strips 30 tothe fabric ring 208 of the mounting ring 200, or to the exterior surfaceof the heart wall 38.

An inlet element 400 (FIG. 3) of an MCSD 401, such as an inlet elementor inflow cannula 400 of MCSD 401 may then be advanced into the openingof heart wall 38 through the bore 204 of the mounting ring 200 andinside of tubular body 14, until a portion of the inflow cannula 400 isdisposed within the heart chamber (Step 814). The particular MCSD 401depicted includes a centrifugal flow pump having a body with a rotordisposed therein and an elongated inlet element projecting from the bodyand having an inlet opening at its end remote from the body (FIG. 3).Because the tubular body 14 does not project proximally from themounting ring 200, the pump may be advanced until body is proximate toor abutting the proximal side of the mounting ring 200, so that theassembly of the pump and mounting ring 200 forms a compact structure onthe outside of the heart. At this stage, the wall of tubular body 14resides between inlet member and mounting ring 200, as best appreciatedwith reference to FIG. 6. Once MCSD 401 is in place, clamp 210 isactuated to constrict the bore of mounting ring 200 so that at least aportion of mounting ring 200 is tightened around inflow cannula 400 tosecuring MCSD 401 into place relative to mounting ring 200 and relativeto the heart (Step 816).

Prior to clamping mounting ring 200 onto inflow cannula 400, theapparatus 100 may move independently of mounting ring 200. However, whenmounting ring 200 is clamped onto inflow cannula 400, tubular body 14 issecured into a fixed position between mounting ring 200 and inflowcannula 400. Thus, tubular body 14 may continue to maintain the positionof flange member 10 against inner surface of heart wall 38. While flangemember 10 and inflow cannula 400 are each positioned against oppositesides of heart wall, flange member 10 is not squeezing, or is onlyslightly squeezing, heart wall 38 against mounting ring 200. Because themounting ring 200 is fastened to the heart wall 38 independently of theflange member 10, the flange member 10 need not bear forcibly on theinside of the heart wall 38 to hold the mounting ring 200 and MCSD 401in place. By limiting the squeezing force that is applied to the heartwall 38 by flange member 10 and mounting ring 200, the potential fornecrosis of heart tissue may be reduced. Once in position, flange member10 may block heart tissues or deposits such as thrombus from enteringthe opening of the inflow cannula 400. In particular, the portion ofheart wall 38 that flange member 10 directly overlies may be preventedfrom being drawn into opening 402 of inflow cannula 400 during operationof MCSD 401. Flange member 10 may also retard growth or deposition oftissue or thrombus around inflow cannula 400.

The apparatus and methods discussed above can be varied in numerousways. For example, the flange member 10 can be brought to its radiallyconstricted condition and advanced through the mounting ring 200 andthrough the opening in the heart wall 38 manually or with the use oftools other than the guiding tube 300 and pusher tube 304 discussedabove. In a further variant, the mounting ring 200, the tubular body 14or both can be provided with fasteners to hold the strips 30 in placetemporarily from the time the strips 30 are folded over to the time theclamp 210 is actuated. For example, the ends of the strips 30 at theproximal end of the tubular body 14 may be provided with hook and loopfasteners and mating fasteners can be provided on the mounting ring 200.In another variant, the strips 30 may have sufficient stiffness suchthat they will remain in place once folded over the proximal end of themounting ring 200, and the folded strips 30 may maintain position of theflange member 10 without any fastening. Conversely, the strips 30 mayhave sufficient length to extend beyond the area covered by the body ofthe MCSD 401, so that the physician can readily hold them while seatingthe MCSD 401 in the mounting ring 200.

The cored hole within heart wall 38 may be any diameter desired foraffixing inflow cannula 402 of MCSD 401. For many MCSDs 401, the coredhole may be approximately 18 mm in diameter. As set forth above, flangemember 10 may be configured so that it may be radially constricted to anextent that will allow flange member 10 to pass through the 18 mmdiameter hole. Flange member 10 may also be configured so that onceflange member 10 is in a position overlying inner surface of heart wall38 that it will radially expand to a sufficient extent so as to preventheart wall material from entering inlet opening 402. For example, flangemember 10 may have a diameter of 35-40 mm or more in its radiallyexpanded condition. The diameter of tubular body 14 may also varydepending on the dimensions of inflow cannula 400 and cored opening inheart wall 38. For example, if the cored opening in heart wall 38 is 18mm the tubular body 14 may have a diameter around 18-20 mm.

While FIGS. 1-6 show flange member 10 as having a circular shape ofuniform thickness, flange member 10 may be configured to have any numberof shapes in accordance with aspects of the disclosure. For example,FIG. 7 shows apparatus having a flange member 10 that varies inthickness in the radial direction, so as to decrease in thickness frominner edge 16 to outer edge 20. This variation in thickness may beconfigured so that flange member 10 may be more readily constricted inthe radial direction during passage through the cored opening of heartwall 38. The flange member 10 may be have non-circular shape. Forexample, the flange member 10 in its radially-expanded condition maytake the shape of a triangle, square, or multi-pointed star. The flangemember 10 may also include a plurality of arms (not shown) that may beconstricted radially so as to allow flange member 10 to pass through anopening of a heart wall, but which mechanically extend out radially fromthe flange member 10 after passage through the opening.

Returning to FIG. 1, tubular body 14 may be provided with any number oftear lines 28. For example, three or four tear lines 28 may be providedso as to create three to four strips 30. In addition, only some of thetear lines 28 may be torn during installation, so as to create fewerteardowns but wider strips 30. In addition, the flexible material oftubular body 14 may be covered in a lacquer (not shown), so as tostiffen the flexible material and allow for the tubular body 14 tomaintain a given shape after placement within the heart wall 38. It isnot essential to provide the tear lines 28 during manufacture; thephysician may simply cut the tubular body 14 during installation to formthe strips 30. In a further variant, the retaining element 12 such asthe tubular body 14 may be crumpled axially or everted duringinstallation so as to reduce projection of the tubular body 14 from theproximal end of the mounting ring 200. Additionally, a plurality of ribs40 may be included on the flange member 10 and radially disposed aboutthe opening 18. For example, as shown in FIG. 1, four ribs 40, which arecomposed of the same material as the flange member 10 may lendadditional stiffness to the flange member 10 such that when the flangemember 10 transition from the first radially constricted condition tothe second radially expanded condition that the flange member 10 formsand maintain the desired radially expanded configuration. Additionally,the flange member 10 may define a plurality of apertures 42 extendingthrough the flange member 10 to facilitate tissue ingrowth into theflange member 10. In the configuration shown in FIG. 1, the plurality ofapertures are radially disposed about the flange member 10.

Different MCSDs 401 may be mounted. For example, the MCSD 401 mayinclude an axial-flow pump having a generally tubular housing with aninlet end and an outlet end. The inlet end of such a housing may serveas the inlet element of the MCSD 401 which is inserted into the heart.Other MCSDs 401 include a pump which is mounted remote from the heartand an elongated, typically flexible, inlet cannula which serves as theinlet element of the MCSD 401. Where such an MCSD 401 is used, thetubular retaining element may continue to protrude proximally from themounting ring. For example, the proximal end of the tubular element neednot be formed into strips or folded over in the manner discussed above.

The retaining element 12 may be formed integrally with the flange member10. In one configuration, the retaining element 12 may incorporate acheck valve such (not shown) as a leaflet valve or duckbill valve toprevent loss of blood from within the heart prior to insertion of theinlet element of the MCSD 401. Such a check valve may be integral withthe retaining element 12, and arranged to allow insertion of the inletelement 400 through the check valve. In yet another variant, theretaining element 12 is not tubular. For example, as shown in FIG. 9 theflange member 10 and a retaining element 12 may be in the form of pluraldiscrete strips 30 extending proximally from the flange member 10.

Although the invention has been described above with reference toparticular embodiments, it is to be understood that these embodimentsare merely illustrative of the principles and applications of thepresent invention. It is therefore to be understood that numerousmodifications may be made to the illustrative embodiments and that otherarrangements may be devised without departing from the spirit and scopeof the present disclosure. The following paragraphs further disclosecertain aspects of the invention.

What is claimed is:
 1. An apparatus for protecting the heart from animplanted inlet element of a blood pump comprising: a flange memberhaving a first radially constricted configuration and a second radiallyexpanded configuration, the flange member being biased in its secondradially expanded configuration, the flange member defining an openingthere through sized to receiving the inlet element of the blood pump;and a retaining element extending from the flange member, the retainingelement being flexible and sized to be disposed about at least a portionof the inlet element, the retaining element defining a tubular bodyhaving a proximal end and a distal end, the tubular body defining anannular pocket distal to the distal end of the tubular body, and whereinthe flange member includes a flexible washer disposed within the annularpocket.
 2. The apparatus of claim 1, further comprising a mountingelement configured for fastening to an exterior surface of the wall ofthe heart independently of the flange member and the retaining element,the mounting element being configured to retain the implanted inletelement in position relative to the heart, the retaining element beingconfigured to engage the mounting element.
 3. The apparatus of claim 2,wherein the mounting element defines a bore and is sized to receive theimplanted inlet element and the retaining element within the bore. 4.The apparatus of claim 3, wherein the mounting element includes a clampconfigured to constrict the bore and engage the retaining elementbetween the implanted inlet element and the mounting element.
 5. Theapparatus of claim 1, wherein the tubular body includes a plurality ofperforation lines extending distally from the proximal end of thetubular body.
 6. The apparatus of claim 1, wherein the retaining elementincludes at least one from group consisting of a knitted material andpolyester.
 7. The apparatus of claim 1, wherein the flange memberincludes a plurality of radially disposed ribs, wherein the ribs areconfigured to bias the flange member in its radially expandedconfiguration.
 8. The apparatus of claim 1, wherein the flange memberincludes a plurality of radially disposed apertures, the radiallydisposed apertures being sized to promote cardiac tissue ingrowth. 9.The apparatus of claim 1, further including a flexible layer of materialcircumferentially disposed around a portion of the retaining element,the flexible layer of material configured to prevent seepage of bloodfrom the heart into an interior of the retaining element.